Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — J.P. Morgan Healthcare Conference 2025
41 slides from Regeneron Pharmaceuticals's conference presentation, Jan 13, 2025
Slide 1: J.P. Morgan Healthcare Conference January 13, 2025
J.P. Morgan Healthcare Conference JANUARY 13, 2025 This non - promotional presentation contains investigational data as well as forward - looking statements; actual results may vary m aterially.
Slide 2: Strategy & Business Update
2 Strategy & Business Update J.P. Morgan Healthcare Conference 2025 Leonard S. Schleifer, MD, PhD Co - Founder, Board Co - Chair, President & Chief Executive Officer
Slide 3: Note regarding forward-looking statements
3 Note regarding forward - looking statements This presentation includes forward - looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc . ("Regeneron" or the "Company"), and actual events or results may differ
Slide 4: Driven by science and innovation
Differentiated technology platforms have delivered 4 ‘blockbuster’ products discovered by Regeneron Unprecedented research and discovery capabilities drive best - in - class pipeline of ~40 product candidates — Includes many near - term opportunities with potential to address therapeutic categories
Slide 5: Driving long-term shareholder value creation
Driving long - term shareholder value creation 5 * Based on preliminary, unaudited results. Continued strong execution across our in - line brands Dupixent now treating over 1 million patients worldwide across 7 approved indications, with new indications expected in 2025 • COPD launch underway; pote
Slide 6: Continued growth and expansion in multiple Type 2 indications
6 Continued growth and expansion in multiple Type 2 indications Q3 2024 Dupixent global net sales of $3.8B (+23% YoY), annualizing at over $15 billion This slide contains investigational indications for dupilumab that have not been approved by any regulatory authority. Approved in SEVEN indications
Slide 7: COPD launch underway in U.S.
7 COPD launch underway in U.S. Dupixent approved by FDA in late September 2024 as an add - on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype • Potential to address ~300,000 patients in the U.S. • Top commercial and Medicare payers authorized D
Slide 8: EYLEA HD + EYLEA U.S. net sales were ~$6 billion in 2024
$4,947 $5,792 $6,265 $5,720 $4,767 * $166 $1,201 2020 2021 2022 2023 2024 8 EYLEA HD + EYLEA U.S. net sales were ~$6 billion * in 2024, up 1% EYLEA HD + EYLEA remained the U.S. anti - VEGF category leader in 2024 *Based on preliminary, unaudited results. U.S. Net Product Sales, in $ Millions Goal to
Slide 9: Strengthening EYLEA HD product profile in 2025
9 Strengthening EYLEA HD product profile in 2025 Delivering key enhancements to EYLEA HD product offering to further unlock ongoing launch Opportunity for EYLEA HD to have broadest indication set with greatest dosing flexibility in anti - VEGF category Convenient Administration • Pre - Filled Syring
Slide 10: LIBTAYO to become next drug above $1B in annual net sales
Strong and consistent growth • WW net sales $850M through 9 months of 2024 (+36% YoY) • Expanding global commercia l footprint 2020 2021 2022 2023 Q1 2024 - Q3 2024 $ 850 M First 9 months of 2024 10 Key growth driver and foundational to oncology portfolio LIBTAYO to become Regeneron’s next internall
Slide 11: Near-term product opportunities and value proposition
11 Value Proposition Indication(s) Anticipated Launch Year Product Category First and only biologic approved for eosinophilic COPD COPD with Type 2 inflammation 2024 Dupixent Eosinophilic COPD Potential first - in class opportunity to address up to 1 million former smokers with COPD globally COPD in
Slide 12: Research & Pipeline Update
12 Research & Pipeline Update J.P. Morgan Healthcare Conference 2025 George D. Yancopoulos, MD, PhD Co - Founder, Board Co - Chair, President & Chief Scientific Officer
Slide 13: Regeneron: A History of Relentless Innovation
3 4 2 1 13 Regeneron: A History of Relentless Innovation Technological breakthroughs yield turnkey platforms that repeatedly deliver practice - changing medicines Genetics, Sequencing & Big Data Novel Combination Modalities Antibody & Bispecific Leadership Technological Breakthroughs Have Delivered
Slide 14: Key 2025 clinical milestones to drive long-term shareholder value
14 This slide contains investigational drug candidates that have not been approved by any regulatory authority. Key 2025 clinical milestones to drive long - term shareholder value Opportunity to address areas of high unmet need in large commercial categories * In combination with LIBTAYO (cemiplimab
Slide 15: Itepekimab (IL-33): next innovation in COPD
P - value 0.091 0.001 0.002 0.005 15 Itepekimab (IL - 33): Regeneron’s next innovation in COPD with pivotal results anticipated in 2H 2025 Building upon Dupixent’s clinical success, potential for benefit in broader COPD population LOF: loss - of - function GOF: gain - of - function This slide contai
Slide 16: Regeneron's oncology strategy: five classes of immunomodulatory agents
Regeneron’s oncology strategy: Using the immune system to defeat cancer with 5 classes of immunomodulatory agents Signal 1 CD3 Bispecifics Designed to link killer T cells with cancer cells Signal 2 Costimulatory Bispecifics Activating killer T cells via costimulation Signal 3 (e.g., Targeted Cytokin
Slide 17: Flexibility of internally-developed oncology pipeline enables novel combinations
Unique flexibility of internally - developed oncology pipeline drives potential for novel and differentiated combinations Cemiplimab (PD - 1) PD1 - IL2Ra - IL2 MUC16 CAR - T Davutamig (METxMET) MUC16 CAR - T Cemiplimab (PD - 1) PD - 1 Inhibitor Odronextamab (CD20xCD3) Linvoseltamab (BCMAxCD3) PSMAxC
Slide 18: First immunotherapy to show DFS benefit in high-risk adjuvant CSCC
18 First immunotherapy to show statistically significant benefit in DFS in high - risk adjuvant Cutaneous Squamous Cell Carcinoma (CSCC) LIBTAYO’s leading position in metastatic CSCC, together with the recent failure of KEYTRUDA ® in adjuvant CSCC, position Regeneron for continued leadership in non
Slide 19: Fianlimab + cemiplimab pooled melanoma data
Fianlimab + cemiplimab pooled POC cohorts ( n=98) Relatlimab (anti - LAG3) + nivolumab (anti - PD1) RELATIVITY - 047 n=355 Ipilimumab (anti - CTLA - 4) + nivolumab CHECKMATE - 067 n=314 Nivolumab (anti - PD - 1) RELATIVITY - 047 n=359 Pembrolizumab (anti - PD - 1) KEYNOTE - 006 n=277 (Q3W regimen) m
Slide 20: Advancing fianlimab and LIBTAYO combination across solid tumors
Phase 3 Phase 2 Phase 1 1L Metastatic Melanoma (vs. pembrolizumab) Melanoma 1L Metastatic Melanoma (vs. nivolumab+relatlimab) Adjuvant Melanoma Perioperative Melanoma Advanced NSCLC NSCLC Perioperative NSCLC Perioperative HCC Other solid tumors 1L HNSCC ( PD - L1+; HPV+ and HPV - ) Perioperative HNS
Slide 21: Pipeline of CD28 costimulatory bispecifics progressing
Combined with: Status / Next Steps Dose Expansion Proof - of - Mechanism Dose Escalation xCD3 bispecifics Checkpoint Inhibitors Enrolling monotherapy and combination cohorts Nezastomig (PSMAxCD28) Prostate Cancer; RCC Expansion cohorts (NSCLC, HNSCC, CSCC, CRC) in combination with cemiplimab and wit
Slide 22: Regeneron's differentiated CD3 bispecifics
Regeneron’s differentiated CD3 bispecifics 22 LINVOSELTAMAB (BCMAxCD3) Multiple myeloma (MM) Linvoseltamab has the potential to be the best - in - class BCMAxCD3 bispecific with its differentiated clinical profile, dosing, and administration ORDSPONO (odronextamab, CD20xCD3) Non - Hodgkin lymphoma (
Slide 23: Exploring differentiated combinations with CD22xCD28
Exploring differentiated combinations (with CD22xCD28) 23 Broad ORDSPONO phase 3 program currently enrolling patients, including in earlier lines of FL and DLBCL Monotherapy efficacy in late lines supports differentiated approach using monotherapy and novel combinations in earlier lines Phase 3 Phas
Slide 24: Odronextamab monotherapy in 1L follicular lymphoma
Unprecedented ORR in late - line setting provides confidence for monotherapy approach in earlier lines; Phase 3 OLYMPIA - 1 trial designed to explore novel, chemotherapy - free, fixed - duration treatment in an outpatient setting in 1L FL 24 Recent data from safety lead - in portion of Ph3 Olympia -
Slide 25: Linvoseltamab data vs approved BCMA bispecifics
* Data source: Jagannath, S. Linvoseltamab, a B - cell maturation antigen - targeted T - cell - engaging bispecific antibody in patients with relapsed or refractory multiple myeloma, including difficult - to - treat subgroups, AACR 2024 § US PI as of April 2024 † Per Protocol. ‡ 30 - min as long as
Slide 26: Broad linvoseltamab development program
26 Broad linvoseltamab development program to evaluate monotherapy and simplified combinations in earlier stages of disease Unprecedented late - line responses rates provide confidence to explore monotherapy and novel combinations in earlier disease settings to simplify treatment approaches † Linvos
Slide 27: Two-pronged approach to anticoagulation with Factor XI antibodies
27 Two - pronged approach to anticoagulation offers potential for improved blood clot prevention and lower bleeding risk Two Factor XI antibodies advancing to pivotal trials in 2025: REGN7508 (catalytic domain) and REGN9933 (A2 domain) 1 Based on maximal aPTT prolongation in human plasma; aPTT - act
Slide 28: Factor XI antibodies: positive proof-of-concept data
28 Regeneron’s Factor XI antibodies: Potential for maximal anti - coagulation with minimal bleeding Positive proof - of - concept data for REGN7508 (catalytic) and REGN9933 (A2) announced in December 2024 *Results from ROXI - VTE I (REGN9933, apixaban) and ROXI - VTE II (REGN7508); enoxaparin VTE ra
Slide 29: Approach to obesity: novel combinations with leading medicines
29 Regeneron’s approach to obesity: novel combinations with leading medicines aim to improve quality of weight loss GLP - 1 based therapies, such as semaglutide (sema) and tirzepatide, are emerging as standards of care for weight loss; however, up to 40% of weight loss from these agents is due to de
Slide 30: Obesity Phase 2 study fully enrolled
30 Obesity Phase 2 study fully enrolled; primary analysis expected to read - out in 2H 2025 Phase 2 study to investigate if addition of trevogrumab (anti - myostatin) to semaglutide with and without garetosmab (anti - activin A) improves the quality of weight loss and/or improves maintenance of weig
Slide 31: Robust pre-clinical obesity and cardiometabolic pipeline
Leveraging decades of expertise to develop a robust pre - clinical obesity and cardiometabolic pipeline 31 Our next wave of therapeutics focuses on GLP1 - independent mechanisms and targeting muscle growth and improved metabolism Goal: To bring next - generation muscle and/or neuro - targeted therap
Slide 32: Linvoseltamab plus Dupixent for severe allergy
32 Novel treatment approach for potentially reversing severe allergy: Linvoseltamab (BCMAxCD3) plus Dupixent (anti - IL4R α ) This slide contains investigational drug candidates that have not been approved by any regulatory authority. Linvoseltamab and Dupixent regimen has the potential to eliminate
Slide 33: Regeneron Genetic Medicines Program
Genetic Medicines Viral vector (e.g. AAV) A ntibody directed delivery siRNA CRISPR/ Cas9 Gene Therapy 33 World - class Regeneron Genetic Medicines (RGM) Program RGM builds and utilizes ‘turnkey’ therapeutic platforms — customizing the choice of genetics technology (siRNA, CRISPR/Cas9, etc.) based on
Slide 34: DB-OTO potential to provide hearing to deaf children
34 DB - OTO demonstrates the potential to provide hearing to deaf children (from infancy to adolescence) DB - OTO is an AAV - based dual - vector gene therapy delivered to the inner ear to enable hearing in children Behavioral pure tone audiogram – a plot of softest sounds a patient can hear in an i
Slide 35: Complement program indications and market opportunity
Program Status 35 2025 U.S. Prevalence (patients): ~1.1M Worldwide market sales * (2025e): ~$1.0B Estimated market sales CAGR* (2025 - 2030): ~34% Geographic Atrophy 2025 U.S. Prevalence (patients): ~6k Worldwide market sales * (2025e): ~$2.0B Estimated market sales CAGR* (2025 - 2030): ~12% Paroxys
Slide 36: Pozelimab + cemdisiran PNH results
Primary Endpoint: % change in lactate dehydrogenase (LDH) from baseline to week 26 in PNH patients 36 Pozelimab + C emdisiran (Poze - Cemdi) enables complete, rapid, uninterrupted and durable inhibition of terminal complement Results from an exploratory cohort in the pivotal PNH trial; safety profil
Slide 37: Regeneron genetic medicines pipeline
37 Regeneron genetic medicines pipeline Phase 3 Phase 2 Phase 1 Select Pre - IND Candidates CIDEB * CIDEB siRNA MASH ALN - HTT02 * HTT siRNA Huntington’s Disease Factor 9 † F9 CRISPR + AAV Hemophilia B GAA † GAA CRISPR + AAV Pompe Disease GJB2/DB - 103 GJB2 AAV GJB2 - related Hearing Loss DB - OTO |
Slide 38: 2025 key upcoming milestones
38 2025 key upcoming milestones EYLEA HD • RVO sBLA acceptance (1H) and FDA decision (2H) • Pre - filled s yringe FDA decision and launch ( mid ) • Addition of 2 - year data in wAMD and DME to FDA label (PDUFA April 20) • Addition of Q4W dosing to FDA label for all indications (2H) Dupixent / I&I •
Slide 39: Q&A
Q&A 39 Leonard S. Schleifer, MD, PhD Co - Founder, Board Co - Chair, President & Chief Executive Officer George D. Yancopoulos, MD, PhD Co - Founder, Board Co - Chair, President & Chief Scientific Officer
Slide 40: Three responsibility focus areas
40 Three responsibility focus areas reflect our “doing well by doing good” ethos OUR MISSION Use the power of science to repeatedly bring new medicines to people with serious diseases 2 Foster a culture of integrity and excellence 1 Improve the lives of people with serious diseases 3 Build sustainab
Slide 41: Abbreviations and Definitions
41 Abbreviations and Definitions Definition Abbreviation First line 1L Adeno - associated virus AAV Amyotrophic lateral sclerosis ALS Activated Partial Thromboplastin Time aPTT Basal cell carcinoma BCC B - cell maturation antigen BCMA Biologics license application BLA Bullous pemphigoid BP Chimeric
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